Lenalidomide & Adriamycin & Dexamethasone (RAD) in Newly... | NCT02471820

NCT02471820

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2011-001499-20	EudraCT Number

Status Module

Description Module

Label	Type	Description	Intervention Names
Lenalidomide, adriamycin & dexamethasone	Experimental	Lenalidomide 25 mg administered orally for the first 21 days of each 28-day-cycle, plus Adriamycin i.v. on days 1,2,3 & 4 of every cycle, plus Dexamethasone 40 mg orally on days 1, 8, 15 & 22 of every cycle for 4 cycles	Drug: Lenalidomide Drug: Adriamycin Drug: Dexamethasone

Name	Type	Description	Arm Group Labels	Other Names
Lenalidomide	Drug	Lenalidomide 25 mg by mouth for the first 21 days of a 28-day-cycle for 4 cycles	Lenalidomide, adriamycin & dexamethasone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall response rate	Assessment of the overall response rate of study population to RAD regimen (including stringent complete response, complete response, very good partial response, partial response and stable disease) according to the uniform criteria of IMWG (International Myeloma Working Group) regarding the response to multiple myeloma therapy	142 days

Measure	Description	Time Frame
Progression-free survival (PFS)		142 days
Time to progression (TTP)		142 days
Time to Next Therapy (TtNT)

Other Outcomes

Measure	Description	Time Frame
Number of stem cell collected before Autologous Stem Cell Transplantation (ASCT)		142 days
Dickkopf-1 (DKK-1)	Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects able to read and understand the Informed Consent Form (ICF).
Subjects willing to participate in the study and comply with its procedures.
Subjects who have signed the ICF
Newly diagnosed patients with symptomatic MM according to the criteria of IMWG
Subjects eligible for autologous stem cell transplantation
Age 18-70 years, of either sex
karnofsky ≥ 60
Platelets ≥ 100x109/L
Neutrophils ≥ 1.5x109/L
Alanine transaminase (ALT) & Aspartate transaminase (AST) ≤ 3-fold of upper normal limit
Bilirubin ≤ 2-fold of upper normal limit
Creatinine clearance ≥60 ml/min
Expected survival ≥ 6 months as per PI's clinical judgment
Subjects able to tolerate aspirin, low molecular weight heparin or coumarinic agents as prophylactic anticoagulation
Female subject of childbearing potential must have 2 negative serum pregnancy tests (hCG) at Screening (once within 10-14 days and once 24 h before the study drug administration) and if sexually active must be using two medically acceptable, highly effective, adequate forms of birth control (ie, failure rate <1% per year when used consistently and correctly) prior to Screening and and for time period at least 28 days before the study drug administration and agree to continue using it while being in the study (Screening and Treatment Periods including dose interruptions). A female subject should continue using a highly effective method of birth control for 30 days following the end of treatment.
A male subject must agree to use an adequate form of contraception for the duration of the study, while taking the study drug, during dose interruptions at for at least 28 days after the last dose of study drug even if he has had a successful vasectomy and agree to have sexual relations only with women who use a highly effective birth control method.
Subjects must be free of any clinically significant disease (other than MM) that would interfere with study evaluations

Exclusion Criteria:

Pregnancy, breastfeeding οr intention of pregnancy during the trial
Suspected or known hypersensitivity to any of the study drugs
Ongoing severe infection requiring intravenous antibiotic treatment
Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the subject has been disease-free for at least 5 years. Concurrent prostate cancer for which the patient is receiving therapy will not be considered an exclusion if the Prostatic specific antigen (PSA) has been stable for 3 years
Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
Myocardial infraction within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
Uncontrolled medical problems such as diabetes, coronary artery disease, hypertension, unstable angina, arrhythmia, pulmonary, hepatic and renal diseases unless renal insufficiency is considered to be secondary to MM
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICF
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she will participate in the study or confounds the ability to interpret data from the study
Subjects with any clinical condition that would affect study's outcome
Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study, except of the clinical trials that implicate drugs of supportive treatment

Name	Affiliation	Role
Meletios Dimopoulos, Doctor	General Hospital of Athens "Alexandra"	Principal Investigator
Eirini Katodritou, Doctor	Theageneio Anticancer Hospital of Thessaloniki	Principal Investigator
Nikolaos Anagnostopoulos, Doctor	General Hospital of Athens "G. Gennimatas''	Principal Investigator
Argirios Symeonidis, Doctor	University General Hospital of Patras	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
General Hospital of Athens "G. Gennimatas"		Athens	Attica	11527	Greece
General Hospital of Athens "Alexandra"

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

ID	Term
D000077269	Lenalidomide
D004317	Doxorubicin
D003907	Dexamethasone

ID	Term
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids